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Indigo Aspiration System – Lightning Aspiration Tubing

K193244 Class II Traditional
Decision Date
2020-03-13
Sponsor / Applicant
Penumbra, Inc.

Technical Specification

510(k) Submission ID K193244
Product Code QEW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5150
Decision Date 2020-03-13
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Indigo Aspiration System – Lightning Aspiration Tubing received FDA 510(k) clearance under submission number K193244, sponsored by Penumbra, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-03-13.

Classification & Regulation

This clearance is catalogued under FDA product code QEW and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.